Download NA/505 - NICNAS

File No: NA/505
Date: July 1997
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
This Assessment has been compiled in accordance with the provisions of the Industrial
Chemicals (Notification and Assessment) Act 1989 (the Act), and Regulations. This
legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals
Notification and Assessment Scheme (NICNAS) is administered by Worksafe Australia
which also conducts the occupational health & safety assessment. The assessment of
environmental hazard is conducted by the Department of the Environment, Sport, and
Territories and the assessment of public health is conducted by the Department of Health
and Family Services.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be
inspected by the public at the Library, Worksafe Australia, 92-94 Parramatta Road,
Camperdown NSW 2050, between the following hours:
Monday - Wednesday
8.30 am - 5.00 pm
Thursday
8.30 am - 8.00 pm
Friday
8.30 am - 5.00 pm
For Enquiries please contact the Administration Coordinator at:
Street Address: 92 Parramatta Rd Camperdown, NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, Sydney 2001, AUSTRALIA
Telephone: (61) (02) 9577-9466 FAX (61) (02) 9577-9465
Director
Chemicals Notification and Assessment
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NA/505
NA/505
FULL PUBLIC REPORT
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
1.
APPLICANT
Lubrizol International Inc. of 28 River Street SILVERWATER NSW 2141 has
submitted a standard notification statement in support of their application for an
assessment certificate for ‘2-acrylamido-2-methylpropanesulfonic acid, ammonium
salt’. No requests for exempt information were made by the notifier and the
assessment report for the notified chemical is published here in its entirety.
2.
IDENTITY OF THE CHEMICAL
Chemical Name:
2-acrylamido-2-methylpropanesulfonic acid,
ammonium salt
Chemical Abstracts Service
(CAS) Registry No.:
58374-69-9
Other Names:
OS 114452
Ammonium AMPS (50% aqueous solution)
OS 114454 (50% aqueous solution)
OS 87613M (50% aqueous solution)
Trade Name:
LZ 2411
Molecular Formula:
C7H13NO4.NH3
Structural Formula:
CH
H2C
NH
C
O
CH2
C
CH3
SO3
NH4
CH3
Molecular Weight:
224 (calculated)
Methods of Detection
and Determination:
ultraviolet/visible, infrared and nuclear magnetic
resonance spectra were provided for the notified
chemical
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Spectral Data:
3.
Major peaks were found in the infrared spectrum
at: 3 304, 1 656, 1 625, 1 548, 1 465, 1 410, 1 376,
1 210, 1 041, 1 107, 965, 915 cm-1
PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20°C
and 101.3 kPa:
white powder
Melting Point:
191°C
[92/69/EEC A1 - Capillary Method (1)]
Boiling Point:
not determined
Specific Gravity:
1.39 at 22°C
[92/69/EEC A3 - Pycnometer (1)]
Vapour Pressure:
7.4 x 10-12 kPa at 25°C
[92/69/EEC A4 - Vapour Pressure Balance (1)]
Water Solubility:
> 761 g/L at 25°C
[92/69/EEC A6 - Shake flask (1)]
Partition Co-efficient
(n-octanol/water):
log Pow = -3.41 at 22°C
[92/69/EEC A8 - Shake flask (1)]
Hydrolysis as a Function
of pH:
not determined - see comments below
Adsorption/Desorption:
Soil Adsorption coefficient < 58.9
Log10 KOC < 1.77
[draft German HPLC Screening Method (2)]
Dissociation Constant:
not determined - see comments below
Surface Activity:
65.8 mN/m at 18.5°C and 1 g/L
[92/69/EEC A5 (1)]
Fat Solubility:
< 0.5 mg/100 g fat at 37.0°C
[84/449/EEC A7 - Flask shaking (1)]
Flash Point:
not determined
Flammability Limits:
not highly flammable
Autoignition Temperature:
> 191°C
Explosive Properties:
nil
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Reactivity/Stability:
non oxidising, contains no oxidising groups
Comments on Physico-Chemical Properties
Tests were performed according to EEC/OECD test guidelines at facilities complying
with OECD Principles of Good Laboratory Practice. The physical and chemical data
are for the pure notified chemical (OS 114452).
Vapour pressure was determined using a vapour pressure balance with
measurements being made at several temperatures and linear regression analysis
used to calculate it at 25°C.
Hydrolysis testing was not performed. However, the notifier supplied test results for
a similar material, 2-acrylamido-2-methylpropanesulfonic acid, sodium salt (the
notified chemical is the ammonium salt).
pH
12
12
Temperature
50°C
80°C
% Hydrolysed
< 10%
50%
At time
7 days
5 days
Hydrolysis results for the parent acid, 2-acrylamido-2-methylpropanesulfonic acid are as
follows:
pH
1
1
Temperature
50°C
80°C
% Hydrolysed
< 1%
50 %
At time
7 days
7 days
Based on these results, and considering the notified chemical’s structure, hydrolysis
under environmental conditions is expected to be extremely slow, ie in the order of
years.
The soil adsorption coefficient indicates that the notified chemical will be highly
mobile in soils (3). This is consistent with its high water solubility. The notified
chemical is an ammonium salt of a sulphonic acid, and as such is expected to
remain highly ionised in the environment.
The notified chemical is not expected to be surface active. By definition, a chemical
has surface activity when the surface tension is less than 60 mN/m (1).
4.
PURITY OF THE CHEMICAL
Degree of Purity:
95-100%
Toxic or Hazardous
Impurities:
none
Non-hazardous Impurities:
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impurities were determined for the parent acid
form of the notified chemical
4
Name
2-acrylamido-2-methyl-1,3-propane-disulfonic
acid, ammonium salt
2-propenamide
2-propenenitrile
N-(1,1-dimethylethyl)-2-propenamide
2-methyl-2-propene-1-sulfonic acid
2-methylene-1,3-propanedisulfonic acid
CAS Number
Weight
—
79-06-1
107-13-1
107-58-4
3934-16-5
1561-93-9
0.5 -1.5%
846 ppm
436 ppm
2138 ppm
26.3 ppm
135 ppm
CAS Number
150-76-5
Weight
424 ppm
Additives/Adjuvants:
Name
4-methoxyphenol
5.
USE, VOLUME AND FORMULATION
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt will not be
manufactured in Australia but will be imported as a 50% aqueous solution for
incorporation into polymers. These polymers are expected to be used mainly in the
paints and adhesive industries.
In a typical polymer, the notified chemical will be at a concentration of approximately
5% by weight. It would be polymerised with other monomers such as ethyl acrylate,
butyl acrylate, vinyl acetate, ethylene, styrene and/or butadiene. The resulting
polymers will be used at a concentration of about 30% in paints or other coatings.
The notified chemical will therefore be present as a polymer component at a
concentration of approximately 1.5%.
Polymers containing 2-acrylamido-2-methylpropanesulfonic acid, ammonium salt are
said by the notifier to have better mechanical stability, and to better stabilise the
paint emulsion.
Overall import volume is expected by the notifier to increase progressively from
5 tonnes in the first year to 50 tonnes in the fifth year of imports.
6.
OCCUPATIONAL EXPOSURE
The notified chemical will be imported as a 50% aqueous solution. Transport of the
chemical to industrial sites for paint or other polymer formation, is expected to be by
truck or rail contained in drums or tank car. Transport workers may be dermally
exposed to the notified chemical while transferring the notified chemical between
bulk containers. During the first year of sales, transport is expected to be in smaller
drum quantities, which will minimise exposure for transport workers.
In a typical application, acrylic monomers and the notified chemical are mixed
together to give the desired latex and polymerisation is initiated. 2-acrylamido-2methylpropanesulfonic acid, ammonium salt would typically represent approximately
5% by weight of the total monomers used. The notifier states that, production of the
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latex is expected by to be a highly automated process utilising appropriate
engineering controls and trained personnel. However the notifier states that they
have no control over the processes employed by clients who purchase the notified
chemical for industrial coatings manufacture. The polymerisation would typically
involve up to four workers per shift, 8 hours per shift. The principal routes of
exposure will be via the skin and inhalation during these processes.
Workers in paint and other surface coatings manufacturing industries may be
exposed to the notified chemical via dermal and inhalation routes when workers
prepare the polymer products. In a typical polymer, the notified chemical would be
present at approximately 5% by weight. The resulting polymer, at about 30%
concentration, is used to make up paints or other coatings where the notified
chemical will be present as a component at approximately 1.5%.
There is also the potential for dermal, inhalational and ocular exposure to the notified
chemical in the form of residual monomer in polymers. This may occur when
professional painters and coating users apply the paint product using spray, brush
or roller equipment. Should contact occur during mixing or application, the paint is
likely to remain on the skin for some time, hence prolonging exposure.
7.
PUBLIC EXPOSURE
The notified chemical will be distributed to customers in drums or tank cars by either
truck or rail, and as such, no public exposure to the notified chemical is expected to
occur during its distribution.
The notifier has stated that although they are not aware of details relating to the
manufacture of polymers, paints and adhesives they anticipate that appropriate
measures will be used to reduce the potential for public exposure to the notified
chemical. Such measures would include, but not be limited to, catch pans,
automated processes and the use of appropriate waste handling procedures.
Disposal of any waste notified chemical will be by incineration. It is anticipated that
any spillage will be appropriately bunded and disposed of. Disposal of the notified
chemical is not expected to result in significant public exposure.
Although the public may come into contact with paints and adhesives containing the
notified chemical, given its low concentration in such end use products, exposure
levels would be low.
8.
ENVIRONMENTAL EXPOSURE
Release
The process by which the notified chemical is polymerised with other monomers is
claimed to be highly automated, using appropriate engineering controls. As such,
any release during the processing is expected to be properly contained. Water will
be used to clean any equipment, such as transfer lines, after use. Any wastes from
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this process, including wash waters, will be disposed of to either licensed facilities
on-site, or to a contract waste water treatment facility. The notifier did not give an
indication of the expected volume of monomer to be disposed of in this way.
However, due to the highly automated process, it is expected that losses through this
route will be small.
The monomer will be supplied to various industrial customers. Polymers,
manufactured using the notified chemical at levels up to 5%, are expected to have
residual levels of the monomer at less than 0.1%. The notifier claims that these
polymers are stable and not expected to decompose or depolymerise to release the
monomer under normal conditions. Thus exposure from the use of paints and other
products containing a polymer manufactured with the notified chemical under normal
conditions of use is minimal.
Fate
The majority of the notified chemical will be incorporated into polymers that will be
used in the manufacture of paints and coatings. As such, the fate of the monomer is
tied to the fate of the polymer, and thus the paint or coatings product. Generally,
paints and coatings cross-link upon curing, resulting in the monomer becoming part
of a solid polymer matrix. As part of a polymerised coat, no hydrolysis, movement,
biodegradation or bioaccumulation of the polymer is expected. Incineration of the
monomer is expected to produce water, and oxides of carbon, nitrogen and sulphur.
Any chips and flakes of the cured paint or coating that occur (due to stone chips,
accidents, wear and tear, etc) will be inert, diffuse and form part of the soil or
sediments.
Losses through polymer manufacture will be sent to a waste water treatment
process. Here the notified chemical is not expected to bind to the soil or organic
fraction of the sludge. It is expected to remain in the aquatic compartment, entering
the environment in the liquid effluent discharged from the plant.
The notified chemical (as a 50% aqueous solution) was evaluated to be not readily
biodegradable in the OECD 301B CO2 Evolution (Modified Sturm) Test (4). At the
end of the 28 day test period, the notified chemical gave a degradation level of
3.22%. The chemical was found to be non-toxic to the microbial populations in the
inoculum, which is consistent with the findings of the separate study, the activated
sludge inhibition test (see the Environmental Effects section below).
The chemical’s high water solubility (> 761 mg/L), resistance to hydrolysis, expected
high degree of ionisation and low log partition coefficient (-3.41) all indicate that it
should not bioaccumulate (5).
9.
EVALUATION OF TOXICOLOGICAL DATA
Toxicity tests were carried out on a number of forms of the notified chemical, as
indicated below:
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9.1
Acute Toxicity
Test Material
OS 87613M
(50% aqueous solution)
OS 114454
(50% aqueous solution)
OS 114452
(notified chemical)
OS 114452
(notified chemical)
OS 114454
(50% aqueous solution)
Test
acute oral
toxicity
acute dermal
toxicity
skin irritation
Species
rat
Outcome
LD50 > 5 000 mg/kg
Reference
(6)
rat
LD50 > 2 000 mg/kg
(7)
rabbit
non-irritant
(8)
eye irritation
rabbit
slight irritant
(9)
skin
sensitisation
guinea
pig
non-sensitising
(10)
9.1.1 Oral Toxicity (6)
Species/strain:
rat/Crl:CD.BR (albino)
Number/sex of animals:
5/sex
Observation period:
14 days
Test material:
OS 87613M (50% aqueous solution)
Method of administration:
gastric intubation
Clinical observations:
diarrhoea in 3 rats on the day of dosing only
Mortality:
nil
Morphological findings:
no test related gross findings
Test method:
similar to OECD guidelines (4)
LD50:
> 5 000 mg/kg
Result:
the notified chemical was of very low acute
toxicity in a limit test in rats
9.1.2 Dermal Toxicity (7)
Species/strain:
rabbit/New Zealand White
Number/sex of animals:
5/sex
Observation period:
14 days
Test material:
OS 87613M (50% aqueous solution)
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Method of administration:
single dose (2 000 mg/kg) applied to a clipped
area of skin, covered with gauze patch and
secured with non irritating tape; dressing was
removed and wiped with deionised water at
24 hours
Clinical observations:
some local irritation was noted at the
application site; all animals gained weight over
period, no other test related clinical findings
Mortality:
nil
Morphological findings:
two animals with red lungs at autopsy; this
result was not obviously test related
Test method:
according to OECD guidelines (4)
LD50:
> 2 000 mg/kg
Result:
the notified chemical was of low acute dermal
toxicity in rabbits
9.1.3 Inhalation Toxicity
Not performed.
9.1.4 Skin Irritation (8)
Species/strain:
rabbit/New Zealand White
Number/sex of animals:
3/sex
Observation period:
3 days
Test material:
OS 114452 (notified chemical)
Method of administration:
0.5 g single dose applied to a clipped area of
skin, moistened with 0.2 mL deionised water,
covered with gauze patch, over-wrapped with
gauze binder, and secured with tape;
dressing was removed and site wiped with
tepid tap water at 4 hours
Draize scores (11):
all erythema and oedema scores from 1 day
after treatment were zero
Test method:
similar to OECD guidelines (4)
Result:
the notified chemical was not a skin irritant in
rabbits
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9.1.5 Eye Irritation (9)
Species/strain:
rabbit/New Zealand White
Number/sex of animals:
3/sex
Observation period:
3 days
Test material:
OS 114452 (notified chemical)
Method of administration:
single 32 mg dose instilled into lower
conjunctival sac of right eye, left eye used as
control
Draize scores (11) of unirrigated eyes:
Time after instillation
Animal
1
a
1 day
2 days
3 days
4 days
7 days
Conjunctiva
ra
cb
dc
ra
cb
dc
ra
cb
dc
ra
cb
dc
ra
cb
dc
1
2
1
0
2
0
0
0
0
0
0
0
0
0
0
0
2
1
1
0
1
0
0
1
0
0
0
0
0
0
0
0
3
1
1
1
1
0
0
1
0
0
0
0
0
0
0
0
4
1
1
0
1
1
0
1
0
0
0
0
0
0
0
0
5
1
0
0
1
0
0
0
0
0
0
0
0
0
0
0
6
1
1
0
1
0
0
1
0
0
0
0
0
0
0
0
see Attachment 1 for Draize scales
redness b chemosis c discharge
All corneal and iridial scores were zero at all times
Test method:
according to OECD guidelines (4)
Result:
the notified chemical is a slight eye irritant
when tested in rabbits
9.1.6 Skin Sensitisation (10)
Species/strain:
guinea pig/Dunkin-Hartley strain
Number of animals:
15 males; 5 control, 10 test
Test material:
OS 114454 (50% aqueous solution)
Induction procedure:
Day 1: 3 pairs of intradermal injections:
0.1 mL Freunds Complete Adjuvant
(FCA): bi-distilled water (1:1 (v/v))
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10
-
0.1 mL of 20% concentration of test
material in water
-
0.1 mL of 20% concentration of test
material in FCA:saline (1:1 (v/v))
Day 7: occluded application of 20%
concentration of test material in
distilled water for 48 hours
Challenge procedure:
Day 14: occluded application of 10% and 5%
solution of test material in distilled
water for 24 hours
Challenge outcome:
Test animals
Control animals
Challenge
concentration
24 hours*
48 hours*
24 hours
48 hours
5%
0/10**
0/10
1/5
1/5
10%
1/10
1/10
0/5
0/5
* time after patch removal
** number of animals exhibiting positive response
9.2
Test method:
according to OECD guidelines (4)
Result:
the notified chemical shows minimal potential
for skin sensitisation in guinea pigs
Repeated Dose Toxicity (12)
Species/strain:
rat/Sprague-Dawley Crl:CD.(SD)BR
Number/sex of animals:
40/sex; Group 1: 10/sex
Group 2: 5/sex
Group 3: 5/sex
Group 4: 10/sex
Group 5: 10/sex
Test material:
OS 114454 (50% aqueous solution)
Method of administration:
oral gavage
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Dose/Study duration:
the test material was administered daily for a
period of 28 days:
Group 1:
0 mg/kg/day
Group 2:
50 mg/kg/day
Group 3: 150 mg/kg/day
Group 4: 400 mg/kg/day
Group 5: 1 000 mg/kg/day
5 animals/sex were maintained from Groups
1, 4 and 5 were maintained for an additional
2 week treatment-free period before sacrifice
Clinical observations:
9.3
possible adverse signs (lethargy, watery stool,
decreased faecal volume) in 1 male for first
week in high dose group (1 000 mg/kg),
recovered by end of week 2, no other
treatment related observations
Clinical
chemistry/Haematology
no treatment related findings
Histopathology:
no treatment related findings
Test method:
according to OECD guidelines (4)
Result:
the notified chemical has very low toxicity
when administered to rats daily for a period of
28 days
Genotoxicity
9.3.1 Salmonella typhimurium Reverse Mutation Assay (13)
Strains:
S. typhimurium TA 98, TA 100, TA 1535,
TA 1537
Test material:
OS 61349H (parent acid)
Concentration range:
0.015, 0.05, 0.15, 0.5, 1.5, 5 mg/plate with and
without S9 mix
Test method:
according to OECD guidelines (4)
Result:
the notified chemical is non-mutagenic in this
system at all concentrations tested
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9.3.2 Micronucleus Assay in the Bone Marrow Cells of the Mouse (14)
9.4
Species/strain:
mice/albino Crl:CD-1 (ICR)BR
Number and sex of animals:
60/sex
Test material:
OS 114454 (notified chemical)
Doses:
175, 875, 1 750 mg/kg
Method of administration:
single intraperitoneal injection
Test method:
according to OECD guidelines (4)
Result:
the notified chemical was non-clastogenic at
all doses tested
Overall Assessment of Toxicological Data
Aqueous solutions containing 50% of the notified chemical exhibited low
acute oral and dermal toxicity in rats (LD50 > 5 000 mg/kg, and 2 000 mg/kg
respectively). Inhalational toxicity studies were not carried out. The notified
chemical was non-irritant to rabbit skin and a slight eye irritant in rabbits. A
50% aqueous solution of the notified chemical showed minimal sensitisation
potential when tested in guinea pigs.
A repeat dose 28 day oral toxicity study carried out in rats with a 50%
aqueous solution of the notified chemical indicated no treatment related toxic
effects.
The parent acid of the notified chemical did not induce a mutagenic response
in bacteria and no clastogenicity was observed when a 50% solution of the
notified chemical was tested in albino mice cells in vitro.
Based on the toxicological studies carried out on the notified chemical, a 50%
aqueous solution of the notified chemical and the parent acid, 2-acrylamido-2methylpropanesulfonic acid, ammonium salt would not be classified as
hazardous according to the Approved Criteria for Classifying Hazardous
Substances (15).
10.
ASSESSMENT OF ENVIRONMENTAL EFFECTS
The following ecotoxicity studies have been supplied by the notifier. They have been
performed on the notified chemical as a 50% aqueous solution (OS 114454), as
imported into Australia. The tests were carried out to OECD Test Methods (4) at
facilities complying with UK Principles of Good Laboratory Practice.
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Test
Acute Toxicity
(Semi-static†)
[OECD TG 203 (4)]
Acute Immobilisation
(Static)
[OECD TG 202 (4)]
Chronic Toxicity
(Reproduction/
Life-cycle)
(Semi-static†)
[OECD TG 202 (4)]
Growth Inhibition
[OECD TG 201 (4)]
Respiration Inhibition
[OECD TG 209 (4)]
Species
Fathead Minnow
(Pimephales promelas)
Results (Nominal◊)
96 hour NOEC = 640 mg/L
96 hour LC50 = 1 400 mg/L
Water Flea
(Daphnia magna)
48 hour NOEC = 640 mg/L
48 hour EC50 = 1 200 mg/L
Water Flea
(Daphnia magna)
Immobilisation (P1)
21 day EC50 = 680 mg/L
Reproduction*
21 day NOEC = 380 mg/L
21 day EC50 > 380 mg/L
96 hour NOEC  2 000 mg/L
96 hour EbC50 > 2 000 mg/L
0-24 hour EC50 > 2 000 mg/L
3 hour EC50 > 10 000 mg/L
Algae
(Selenastrum
capricornutum)
Aerobic Waste Water
Bacteria
(Activated Sludge)
◊ All results are expressed in terms of nominal concentrations as analytical concentrations closely
followed the nominal concentrations. In the fish toxicity test measured concentrations ranged from
100-103% of nominal at 0 hours, 99-105% at 24 hours and 101-103% of nominal at 96 hours. In
the water flea acute toxicity test the measured concentrations ranged 93-98% and 95-100% of
nominal at 0 hours and 48 hours, respectively. In the water flea chronic toxicity test, measured
concentrations were shown to be near nominal except for the 12 mg/L test group on days 16 and
21 which showed measured concentrations of 218 and 214% of nominal respectively. Measured
concentrations were 96-97% of nominal at 0 hours and 100-102% of nominal at 96 hours in the
algae growth inhibition test.
† Animals were exposed to the test media with daily batchwise renewal.
* The 21 day EC50 (reproduction) is considered to lie between 380 and 1 200 mg/L, given that on
days 14 and 21, at the test concentration of 380 mg/L, there were no significant differences in
terms of the number of young produced per adult when compared to the control. Statistical
analysis for the 1 200 mg/L test group could not be carried out for days 14 and 21 as those
surviving adults reaching maturity were observed to produce no offspring and were all eliminated
by day 16 of the study. The total number of young produced over the 21 days for the 380 mg/L
test concentration was observed to be 88% of the total number of young produced by the control.
The ecotoxicity data for the notified chemical indicate that the notified chemical (in its
imported form as a 50% aqueous solution) is practically non-toxic to fish, water fleas
and algae. No inhibition of microbial activity was seen in the study for the 3 hour
contact time.
11.
ASSESSMENT OF ENVIRONMENTAL HAZARD
The environmental hazard from the notified chemical is rated as low. The majority of
the monomer will be used in polymer manufacture. Residual levels of the monomer
are expected to be present in the polymer at low levels (< 0.1%). Once the
monomer is incorporated into the polymer, the properties and toxicity will change to
reflect that of the polymer. Therefore, further environmental hazard can not be
determined.
Aquatic exposure to the notified chemical is likely to occur through the release of
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effluent from the waste water treatment plants. However, due to the automated
processes involved in polymer formulation, losses through this route are expected to
be small. Also, the notified chemical should only be present in the effluent at very
low concentrations due to dilution factors. It was shown that the notified chemical is
practically non-toxic to aquatic species. The environmental hazard through this
disposal is predicted to be low.
The only other sources of environmental contamination are from accidental spills and
disposal of packaging. The Material Safety Data Sheet (MSDS) is adequate to limit
environmental exposure and therefore limit the environmental effects.
12.
ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt is very water soluble
with low molecular weight and likely to be highly chemically reactive through its
acrylic moiety, which is active in the polymerisation reaction. Its physical properties
are likely to aid in uptake through the skin or eyes if accidentally contacted.
Waterside, warehouse and transport workers are unlikely to be exposed to the
notified chemical under normal circumstances, although some dermal contact may
occur when the notified chemical is transferred between bulk containers. Should
exposure occur in the event of an accident, results of toxicity studies provided by the
notifier suggest that there would not be significant hazard to workers acutely
exposed in such an incident.
The occupational health risk posed to workers who will be involoved in polymer
manufacture is low. Exposure to the notified chemical is expected to be minimal, as
the notifier states that polymer manufacturing processes will be highly automated. In
addition, the toxicological hazard is low, based on the results of tests provided by the
notifier.
The occupational health risk posed to workers in paint and other surface coatings
manufacturing industries is also low, as the notified chemical will be present as a
polymer component at a concentration of approximately 1.5%. As the notified
chemical will be part of the polymer structure, it is not expected to be bioavailable in
this form.
There is potential for dermal, inhalational and ocular exposure to the notified
chemical in the form of residual monomers in polymers. Professional painters and
coating users may be exposed when applying paint products using spray, brush or
roller equipment. Should contact occur during mixing or application, the paint is
likely to remain on the skin for some time, hence prolonging exposure. There may
be significant worker contact in this way, however, the notified chemical should be
almost completely reacted into the polymer and is unlikely to be bioavailable.
The results of toxicological tests supplied by the notifier suggest no significant
hazardous properties for the notified chemical. However substituted acrylamides
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NA/505
15
have been shown in long range tests to possess neurotoxic and carcinogenic
properties which may not be detected in the range of tests presently conducted (16).
Workers who may be potentially exposed repeatedly over a long period should be
careful to wear protective clothing and maintain good ventilation in the working
environment to minimise the possibility of chronic exposure.
The public is not expected to be exposed to the notified chemical during the
manufacture of polymers, paints and adhesives. Given its low concentration in such
products, it is unlikely to constitute a hazard to public health.
13.
RECOMMENDATIONS
To minimise occupational exposure to 2-acrylamido-2-methylpropanesulfonic acid,
ammonium salt the following guidelines and precautions should be observed:

It is good work practice to wear industrial clothing which conforms to the
specifications detailed in Australian Standard (AS) 2919 (17) and occupational
footwear which conforms to Australian and New Zealand Standard (AS/NZS)
2210 (18) to minimise exposure when handling any industrial chemical;

Spillage of the notified chemical should be avoided, spillages should be cleaned
up promptly and put into containers for disposal;

Good personal hygiene should be practised to minimise the potential for
ingestion;

A copy of the MSDS should be easily accessible to employees.
14.
MATERIAL SAFETY DATA SHEET
The MSDS for the notified chemical was provided in accordance with the National
Code of Practice for the Preparation of Material Safety Data Sheets (19).
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information
remains the responsibility of the applicant.
15.
REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, secondary notification of the notified chemical shall be required if any
of the circumstances stipulated under subsection 64(2) of the Act arise. No other
specific conditions are prescribed.
FULL PUBLIC REPORT
NA/505
16
16.
REFERENCES
1.
European Economic Community (EEC) 1992, 'Methods for the Determination
of Physico-Chemical Properties', in EEC Directive 92/69, Annex V, Part A,
EEC Publication No. L383, EEC.
2.
Kordel, W. , HPLC-Screening Method for the Determination of the
Adsorption-Coefficient on the Soil-Comparison of Different Stationary Phases,
Institut fur Umweltchemie and Okotoxikologie
3.
McCall, J., Laskowski, R. & Dishburger, H. 1981, 'Measurement of Sorption
Coefficients of Organic Chemicals and Their Use In Environmental Fate
Analysis', in Test protocols for environmental fate and movement of toxicants.
Proceedings of a symposium, Association of Official Analytical Chemists,
Washington DC, pp. 89-109.
4.
Organisation for Economic Co-operation and Development 1995-1996, OECD
Guidelines for the Testing of Chemicals on CD-Rom, OECD, Paris.
5.
Connell, D.W. 1989, 'General characteristics of organic compounds which
exhibit bioaccumulation', in Bioaccumulation of Xenobiotic Compounds, CRC
Press, Boca Raton.
6.
Kiplinger, B. 1993, Acute Oral Toxicity Study of OS#87613M in Albino Rats,
Project no., WIL-168097, WIL Research Laboratories, Inc., USA.
7.
Varsho, B. 1996, Acute Dermal Toxicity Study of OS 114454 in Albino Rats,
Project no., WIL-168111, WIL Research Laboritories, Inc., USA.
8.
Varsho, B. 1996, Primary Dermal Irritation Study of OS 114452 in Albino
Rabbits, Project no., WIL-168112, WIL Research Laboritories, Inc., USA.
9.
Varsho, B. 1996, Primary Eye Irritation Study of OS 114452 in Albino
Rabbits, Project no., WIL-168113, WIL Research Laboritories, Inc., USA.
10.
Liggett, M. 1996, OS 114454 Skin Sensitisation Study in the Guinea Pig,
Project no., LBL 20/960588/SS, Huntingdon Life Sciences Ltd, England.
11.
Draize, J.H. 1959, 'Appraisal of the Safety of Chemicals in Foods, Drugs and
Cosmetics', Association of Food and Drug Officials of the US, vol. 49, pp. 256.
12.
Bond, P. 1996, A 4-Week Toxicity Study of OS 114454 in the Rat Via Oral
Gavage Administration Followed by a 2-Week Recovery Period, Project no.,
95-2442, Huntingdon Life Sciences, USA.
13.
Loveday, K. 1991, Evaluation of OS 61349H in a Bacterial Mutagenesis
Study, Project no., 64919-11, Arthur D. Little, Inc, USA.
FULL PUBLIC REPORT
NA/505
17
14.
Stankowski, L. 1996, In vivo Micronucleus Test with OS# 114454 in Mouse
Bone Marrow Erythropoietic Cells, Project no., 0309EL02.001, Pharmakon
USA, USA.
15.
National Occupational Health and Safety Commission 1994, Approved
Criteria for Classifying Hazardous Substances [NOHSC:1008(1994)],
Australian Government Publishing Service, Canberra.
16.
World Health Organisation (WHO) 1985, Environmental Health Criteria 49:
Acrylamide, WHO, Geneva.
17.
Standards Australia 1987, Australian Standard 2919-1987, Industrial Clothing,
Standards Association of Australia, Sydney.
18.
Standards Australia/Standards New Zealand 1994, Australian/New Zealand
Standard 2210-1994, Occupational Protective Footwear, Standards
Association of Australia/Standards Association of New Zealand,
Sydney/Wellington.
19.
National Occupational Health and Safety Commission 1994, National Code of
Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)], Australian Government Publishing Service, Canberra.
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NA/505
18
Attachment 1
The Draize Scale for evaluation of skin reactions is as follows:
Erythema Formation
Rating
Oedema Formation
Rating
No erythema
0
No oedema
0
Very slight erythema (barely
perceptible)
1
Very slight oedema (barely
perceptible)
1
Well-defined erythema
2
Slight oedema (edges of area welldefined by definite raising
2
Moderate to severe erythema
3
Moderate oedema (raised approx. 1
mm)
3
Severe erythema (beet redness)
4
Severe oedema (raised more than 1
mm and extending beyond area of
exposure)
4
The Draize scale for evaluation of eye reactions is as follows:
CORNEA
Opacity
Rating
Area of Cornea involved
Rating
No opacity
0 none
25% or less (not zero)
1
Diffuse area, details of iris clearly
visible
1 slight
25% to 50%
2
Easily visible translucent areas,
details of iris slightly obscure
2 mild
50% to 75%
3
Opalescent areas, no details of iris
visible, size of pupil barely
discernible
3
moderate
Greater than 75%
4
Opaque, iris invisible
4 severe
CONJUNCTIVAE
Redness
Rating
Chemosis
Rating
Discharge
Rating
Vessels normal
0 none
No swelling
0 none
No discharge
0 none
Vessels definitely
injected above normal
1
slight
Any swelling above
normal
1 slight
Any amount different
from normal
1 slight
More diffuse, deeper
crimson red with
individual vessels not
easily discernible
2 mod.
Obvious swelling
with partial eversion
of lids
2 mild
Discharge with
moistening of lids and
adjacent hairs
2 mod.
3
severe
Swelling with lids
half-closed
3 mod.
Diffuse beefy red
3
severe
Swelling with lids
half-closed to
completely closed
4
severe
Discharge with
moistening of lids and
hairs and
considerable area
around eye
IRIS
Values
Rating
Normal
0 none
Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light
1 slight
No reaction to light, haemorrhage, gross destruction
2 severe
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